1. Stem cell collection and hematological recovery in the Fondazione Italiana Linfomi (FIL) MCL0208 clinical trial
- Author
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Michele Clerico, Simone Ferrero, Beatrice Alessandria, Gian Maria Zaccaria, Elisa Genuardi, Simone Ragaini, Rita Tavarozzi, Federica Cavallo, Stefan Hohaus, Gerardo Musuraca, Angelo Michele Carella, Caterina Stelitano, Monica Tani, Gianluca Gaidano, Jacopo Olivieri, Sara Veronica Usai, Sara Galimberti, Francesca Re, Michael Mian, Claudia Castellino, Vincenzo Pavone, Andrea Evangelista, Benedetto Bruno, Sergio Cortelazzo, Roberto Passera, and Marco Ladetto
- Subjects
Mantle cell lymphoma (MCL) ,Autologous stem cell transplantation (ASCT) ,Peripheral blood stem cells (PBSC) ,Leukapheresis (LK) ,Hematological recovery ,Medicine ,Science - Abstract
Abstract In the frontline high-dose phase 3 FIL-MCL0208 trial (NCT02354313), 8% of enrolled mantle cell lymphoma (MCL) patients could not be randomised to receive lenalidomide (LEN) maintenance vs observation after autologous stem cell transplantation (ASCT) due to inadequate hematological recovery and 52% of those who started LEN, needed a dose reduction due to toxicity. We therefore focused on the role played by CD34 + hematopoietic stem cells (PBSC) harvesting and reinfusion on toxicity and outcome. Overall, 90% (n = 245) of enrolled patients who underwent the first leukapheresis collected ≥ 4 × 106 PBSC/kg, 2.6% (n = 7) mobilized 10 days) was associated with a worse outcome, both in terms of PFS and OS. In conclusion, although the harvesting procedures proved feasible for younger MCL patients, long-lasting cytopenia following ASCT remains a significant issue: this can hinder the administration of effective maintenance therapies, potentially increasing the relapse rate and negatively affecting survival outcomes.
- Published
- 2024
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